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Validation Study Of A Digital Measuring Device For Central Hand Representation In Children With A Neonatal Brachial Plexus Palsy

Implicit Central Hand Representation in Children With Neonatal Brachial Plexus Palsy: Interrater and Intrarater Reliability of the HandUZ Device - A Validation Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06950879
Enrollment
18
Registered
2025-04-30
Start date
2025-01-25
Completion date
2025-05-01
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Brachial Plexus Palsy

Brief summary

Hand function is one of the most complex and sophisticated sensorimotor skills, controlled by the interplay of precise motor efferent and multisensory afferent stimuli. A coherent central representation of the hand is essential for performing hand movements in a changing environment. However, the hand representation in the brain consists of many modalities (visual, proprioceptive, anthropometric,...). The division between explicit (conscious) and implicit (unconscious) representation of the hand is accepted by a large group of researchers. The explicit representation of the hand is based partly on visual afferents, the implicit on all other afferent inputs. Impaired hand function in everyday use after injury may be due to aberrant hand representation. Previous research showed that children with neonatal brachial plexus injury have impaired implicit hand representation with respect to hand size. Despite the good reproducibility of test results reported in the literature, the measurement method is very cumbersome. In the current technological revolution, digitalisation of the device is the ideal solution to make the measurement method clinically applicable in daily practice. Therefore, a new prototype digital device has been developed to automate the measurement method. This prototype works on the same principle and has the same dimensions as previous studies. It includes digital storage and processing of the measurement results. This study investigates the reproducibility (inter- and intra-observer) of the digital prototype. The study will recruit children aged between 8 and 18 years with a neonatal brachial plexus injury. Doctors treating this patient group will explain the study during consultations and provide a flyer. Participation in the study means that the patient will be invited to the UZ Ghent Paediatric Rehabilitation Centre, where two different doctors will independently perform the measurement. Specifically, they will be asked to place their hand on a mat and the fingertips, knuckles and wrist will be marked on the device. A wooden board is then placed over the hand so that the hand is no longer visible. The subject is then asked to indicate the fingertips, knuckles and wrist in random order, again recorded on the device. The test takes 5 to a maximum of 10 minutes (depending on cooperation). This measurement is repeated a 6 times on each hand. Based on these measurements, the device calculates the average of each participant's perceived hand width and finger length. These values are compared with the actual hand width and finger length. This allows us to calculate a percentage of overestimation. Studies using such data have already been published. The aim of this study is to measure the reproducibility (inter- and intraobserver) of the digitised version.

Interventions

A wooden construction was built consisting of two plates with dimensions of 35 x 29 cm: a bottom plate, with a measuring mat glued to it, a movable middle plate and a smaller top plate, allowing to mount a standardized overhead camera. Participants were seated and placed one hand palm down on the measuring mat on the bottom plate. The hand was aligned with the midline of the body, lay flat with the fingers straight and lightly spread. First the actual landmarks were marked on the computer. Subsequently the participants hand was occluded by adding the middle plate. Participants were verbally cued to mark a certain landmark with their contralateral hand. These indicated points were marked on the computer. Before and after each trial, a picture was taken without the occluding board to ensure that the hand had not moved from its original position by digitally overlaying the images

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Presence of a Neonatal Brachial Plexus Palsy

Exclusion criteria

* Presence of any other important locomotor, neurological or psychiatric disorder

Design outcomes

Primary

MeasureTime frameDescription
Intrarater Reliability of Implicit Finger Length Estimates Using the HandUZ DeviceSingle session (approximately 45 minutes)Intrarater reliability was assessed using the intraclass correlation coefficient (ICC\[3,1\]) based on two sets of averaged finger length estimates (FL) per participant, measured across two time points by the same rater. FL was calculated in centimeters as the Euclidean distance between the fingertip and metacarpophalangeal (MCP) joint for each digit. Data were averaged across fingers and hands to yield a single participant-level value. ICCs were calculated using a two-way mixed-effects model, absolute agreement. A higher ICC indicates greater measurement reliability. Each participant contributed two independent values (left and right hand), but the unit of analysis is the participant. Results for both hands are reported in separate rows.

Secondary

MeasureTime frameDescription
Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ DeviceSingle session (approximately 45 minutes)Interrater reliability was assessed using the intraclass correlation coefficient (ICC\[3,1\]) based on two sets of averaged finger length estimates (FL) measured independently by two trained raters. FL was computed per finger (in cm) as the Euclidean distance between fingertip and MCP joint using HandUZ software. Values were averaged across fingers and hands. ICCs were calculated using a two-way mixed-effects model, absolute agreement. Separate ICC values are provided for the left and right hands in the results table, but both are reported under this single outcome measure. Each participant contributed two independent values (left and right hand), but the unit of analysis is the participant. Results for both hands are reported in separate rows

Countries

Belgium

Participant flow

Recruitment details

Participants were recruited between Januari and April 2025 at the Child Rehabilitation Centre of Ghent University Hospital. Eligible children with a confirmed diagnosis of neonatal brachial plexus palsy (NBPP) were identified during regular consultations at the multidisciplinary NBPP clinic. Information about the study was provided verbally and in writing to families. A total of 18 participants aged 8- 18 were included.

Participants by arm

ArmCount
Participants
17 children aged 8-18 with a neonatal brachial plexus palsy.
17
Total17

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyUnable to complete task due to motor impairment1

Baseline characteristics

CharacteristicParticipants
Age, Categorical
<=18 years
17 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 17
other
Total, other adverse events
0 / 17
serious
Total, serious adverse events
0 / 17

Outcome results

Primary

Intrarater Reliability of Implicit Finger Length Estimates Using the HandUZ Device

Intrarater reliability was assessed using the intraclass correlation coefficient (ICC\[3,1\]) based on two sets of averaged finger length estimates (FL) per participant, measured across two time points by the same rater. FL was calculated in centimeters as the Euclidean distance between the fingertip and metacarpophalangeal (MCP) joint for each digit. Data were averaged across fingers and hands to yield a single participant-level value. ICCs were calculated using a two-way mixed-effects model, absolute agreement. A higher ICC indicates greater measurement reliability. Each participant contributed two independent values (left and right hand), but the unit of analysis is the participant. Results for both hands are reported in separate rows.

Time frame: Single session (approximately 45 minutes)

ArmMeasureGroupValue (NUMBER)
ParticipantsIntrarater Reliability of Implicit Finger Length Estimates Using the HandUZ DeviceLeft hand0.91 Intraclass Correlation Coefficient
ParticipantsIntrarater Reliability of Implicit Finger Length Estimates Using the HandUZ DeviceRight hand0.92 Intraclass Correlation Coefficient
Secondary

Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ Device

Interrater reliability was assessed using the intraclass correlation coefficient (ICC\[3,1\]) based on two sets of averaged finger length estimates (FL) measured independently by two trained raters. FL was computed per finger (in cm) as the Euclidean distance between fingertip and MCP joint using HandUZ software. Values were averaged across fingers and hands. ICCs were calculated using a two-way mixed-effects model, absolute agreement. Separate ICC values are provided for the left and right hands in the results table, but both are reported under this single outcome measure. Each participant contributed two independent values (left and right hand), but the unit of analysis is the participant. Results for both hands are reported in separate rows

Time frame: Single session (approximately 45 minutes)

ArmMeasureGroupValue (NUMBER)
ParticipantsInterrater Reliability of Implicit Finger Length Estimates Using the HandUZ DeviceLeft hand0.72 Intraclass Correlation Coefficient
ParticipantsInterrater Reliability of Implicit Finger Length Estimates Using the HandUZ DeviceRight hand0.71 Intraclass Correlation Coefficient

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026